An interventional study of Physical exercise and Nutrition supplement in Rectal Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Fudan University · Not applicable, Interventional, and Supportive care
The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.
This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma；(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 108 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
6-week trimodel prehabilitation program consists of physical exercises, nutrition supplement and mental support for patients with rectal cancer during neoadjuvant chemotherapy before surgery. All patients will receive ERAS care pattern after surgery.
Behavioral: Physical exercise · Dietary Supplement: Nutrition supplement · Behavioral: Mental support
Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care.
Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Oral nutrition supplement (ENSURE) is provided daily seperated in 2 doses
Relaxation exercise and psychological counselling delivered by weekly telephone follow-up
Functional outcome
Walking capacity measured by 6-minute walking distance (6MWD)
Time frame: at baseline, before surgery, 4 weeks and 8 weeks after surgery
perioperative complication
measured by comprehensive complication index (CCI)
Time frame: recorded from the day of surgery to 30 days after surgery
Nutrition status
measured by BMI and SMI
Time frame: at baseline, before surgery, 4 and 8 weeks after discharge
Patient-reported outcome measures
using SF-36
Time frame: at baseline, before surgery and 30days after discharge
immune function markers
specific immnue cells like CD4/CD8, cytokines, peripheral blood test.
Time frame: at baseline, before surgery, 4 and 8 weeks after discharge
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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